Director, Regulatory CMC
As a Director you will be responsible for leading CMC regulatory strategy development and implementation that incorporates risk identification and contingency planning for assigned Global post approval biotechnology submissions. You will also be a key player in interactions with Global Regulatory Authorities, as necessary, to support CMC post-marketing activities for assigned programs. You are expected to partner with Manufacturing Operations to establish alignment with the product regulatory strategies and to communicate regulatory CMC requirements to team members both internally and externally. This role requires knowledge of device/combination product regulations.
- Taking a leadership role in establishing product specific strategies to ensure successful development of CMC packages to support Global/Rest of World registration and life cycle management.
- Partnering with Regulatory Affairs Global Regulatory Leads to ensure alignment of strategy for a variety of monoclonal antibody programs.
- Participating on due diligence teams as necessary.
- Coordinate CMC regulatory sections for submission to Health Authorities.
- Participate and/or lead various multi-disciplinary teams or taskforces related to CMC.
- Lead interactions with Health Authorities as they pertain to CMC post-marketing issues.
- Liaise with all relevant groups to ensure high quality CMC documentation is developed
- Lead development of all major CTD submission elements relating to CMC and effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues.
- Meets with relevant individual/groups on regular basis to provide input on major regulatory CMC submissions.
- Interact effectively with external business partners.
Essential Skills Required
- BS/MS or Ph.D. in a scientific discipline
- Experience working directly in Regulatory Affairs – CMC
- Extensive experience and increasing documented success in a biopharmaceutical field specifically working on biotechnology-based products or complex biologics
- Post-marketing submission experience is required
- Advanced understanding of regulations and guidance governing the manufacture of biotechnology products, especially monoclonal antibodies
- Be able to work independently and problem solve/find solutions.
- Direct Regulatory Affairs CMC experience with submissions for biologic and biotechnology derived products such as monoclonal antibodies or complex biologic products is required.
- Ph.D. in a related field
- Technical experience in the testing or manufacture of biotechnology-derived products or complex biologics.
- Experience working directly for a Health Authority in a related position.
- Experience working with the requirements of a product delivered by a pre-filled syringe and autoinjector
- Knowledge of regulatory requirements from a CMC perspective for products administered via pre-filled syringe and/or autoinjector
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.